Many manufacturers underestimate EU IVDR Performance Evaluation until a Notified Body review exposes the gaps — by which point, the cost of getting it wrong is already significant.
Performance Evaluation is not simply a regulatory requirement to be completed and filed away. It is the core mechanism through which a manufacturer demonstrates that a device is safe, performs as intended, and generates results that are both analytically sound and clinically supported.
Under Regulation (EU) 2017/746, every IVD must be supported by a structured and continuously updated Performance Evaluation, culminating in a Performance Evaluation Report (PER) that withstands detailed scrutiny from a Notified Body.
Yet for many manufacturers, Performance Evaluation remains one of the least well-understood aspects of IVDR compliance. This article sets out what the regulation actually requires, where manufacturers most commonly fall short, and what a strategic approach to Performance Evaluation looks like in practice.
Start with a plan
Antoine de Saint-Exupéry (1900–1944), a pioneering French aviator, once said:
"A goal without a plan is just a wish."
Central to the Performance Evaluation is the PEP (Performance Evaluation Plan), which sets out in advance how Performance Evaluation activities will be conducted. The PEP defines the intended purpose, identifies the data required to demonstrate scientific validity, analytical and clinical performance, and describes the methods for data generation, collection, and appraisal. It also establishes acceptance criteria and outlines how gaps in evidence will be addressed.
The three pillars of Performance Evaluation
At its core, Performance Evaluation brings together three interconnected pillars:
- scientific validity,
- analytical performance, and
- clinical performance.
Scientific validity establishes the relationship between the analyte and the clinical condition of interest. This includes a structured literature review demonstrating the association between the analyte and the clinical condition. The expectation is that the manufacturer demonstrates a clear, evidence-based rationale for why the analyte is clinically relevant for the intended use.
Analytical performance demonstrates that the device can reliably detect or measure that analyte. This focuses on the technical capability of the device, and includes studies on parameters such as accuracy, precision, analytical sensitivity and specificity, limit of detection, measuring range, reproducibility, and potential interferences.
These studies are often generated in-house, but they must be designed and documented in a way that aligns with recognised standards and reflects real-world use conditions. The report must also explain how the results support the device’s claimed performance characteristics.
Clinical performance then shows that the test results correlate with a clinical condition or outcome in the intended population. This may be based on clinical performance studies, published literature, or a combination of both. Under IVDR, there is a clear expectation that the data are directly relevant to the specific device and its intended use.
Bringing the evidence together
The challenge lies not just in generating these data, but in integrating them into a coherent, evidence-based argument that supports the intended purpose of the device, confirms compliance with the General Safety and Performance Requirements, and demonstrates a favourable benefit-risk profile.
These documents collectively feed into the Performance Evaluation Report (PER), where the data are brought together, critically appraised, and translated into conclusions. The PER must demonstrate consistency across all elements — showing that the scientific validity supports the analytical performance, which in turn supports the clinical performance, all aligned with the intended purpose.
Any gaps, limitations, or uncertainties must be clearly identified and addressed, including through post-market performance follow-up where necessary.
Where manufacturers run into difficulty
In practice, the Performance Evaluation is where many manufacturers encounter difficulty. One of the most common issues is the translation of intended purpose into an appropriate body of evidence. Intended purpose statements are often broader than the available data can robustly support, and even small malalignments between claims and evidence can lead to significant regulatory concerns.
IVDR expects a critical appraisal of all data, including an assessment of study design, potential bias, statistical robustness, and clinical applicability. Manufacturers must justify why certain data are included or excluded, and explain how the totality of evidence supports their conclusions. This level of scrutiny means that Performance Evaluation becomes an exercise in scientific reasoning as much as regulatory compliance.
Presentation matters as much as the data
Even when sufficient data exist, the way the Performance Evaluation is structured and presented can determine whether it is accepted. Notified Bodies expect a clear, logical narrative that links the PEP, the individual scientific validity, analytical and clinical performance reports, and the final PER conclusions.
Inconsistencies between these documents are a frequent source of nonconformities. Typical findings include:
- Insufficient clinical evidence to support claims
- Weak connections between data and conclusions
- Inadequate justification for the use of literature
- Poorly defined acceptance criteria in the PEP
- A lack of critical appraisal across the supporting reports
In many cases, the underlying issue is not the absence of data, but the inability to interpret and present it in a way that meets regulatory expectations.
A strategic approach pays dividends
Manufacturers that approach Performance Evaluation strategically tend to achieve better outcomes. This means:
- Defining a precise and realistic intended purpose early in development
- Planning evidence generation through a well-constructed PEP
- Ensuring alignment across all supporting documents
It also means recognising that Performance Evaluation is an ongoing, interconnected system of documents rather than a single report.
Start your IVDR journey with confidence
Performance Evaluation under IVDR is not a document exercise — it is a demonstration of scientific rigour, and Notified Bodies will scrutinise it as such.
Manufacturers who invest in getting the fundamentals right, from a well-structured PEP through to a coherent PER, are considerably better placed to achieve and maintain CE marking.
If you’re ready to take that first step, we’re offering a free PEP to qualifying manufacturers. Contact us today to check if you’re eligible.
